Number of Subjects With Clinical Adverse Experiences (CAEs) [ Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first ] [ Designated as safety issue: Yes ]

Subjects in this study were followed for all CAEs, including intussusception. A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product

Number of Subjects With Serious Clinical Adverse Experiences (SCAEs) [ Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first ] [ Designated as safety issue: Yes ]

Subjects were followed for all SCAEs. SCAEs are any CAEs occurring at any dose that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.

Number of Subjects With Vaccine-Related Clinical AEs (CAEs) [ Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first ] [ Designated as safety issue: Yes ]

CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator, who is a qualified physician, as being related to the vaccine according to his/her best clinical judgment.

Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs) [ Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first ] [ Designated as safety issue: Yes ]

Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose

Number of Subjects Discontinued Due to Clinical Adverse Experiences [ Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first ] [ Designated as safety issue: Yes ]

A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.

Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs) [ Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first ] [ Designated as safety issue: Yes ]

CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator who is a qualified physician as being related to the vaccine according to his/her best clinical judgment.

Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs) [ Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first ] [ Designated as safety issue: No ]

SCAEs are any CAEs that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.

Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs) [ Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first ] [ Designated as safety issue: No ]

Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.

weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination

Eligibility

Ages Eligible for Study:

6 Weeks to 12 Weeks (Child)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Healthy infants

Exclusion Criteria:

History of abdominal disorders from a birth defect, intussusception, or abdominal surgery

Known or suspected problems with the immune system

Fever at time of immunization

Prior administration of a rotavirus vaccine

History of known prior rotavirus disease, chronic diarrhea, or failure to thrive.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092456